FDA, Small Businesses Work to Develop Countermeasures to Public Health Threats
Mounting an effective response to an emerging public health threat is a critical responsibility of the U.S. Food and Drug Administration. History has shown that natural or man-made threats can appear rapidly, affect large numbers of people, and last for some time.
For many of these threats, medical countermeasures (MCM) -- the drugs, vaccines, diagnostic devices, and other medical equipment critical to counter unintentional or deliberate threats involving a chemical, biological, radioactive, or nuclear agent or an emerging infectious disease threat – represent a lifeline to an ailing public.
FDA oversees development of human and veterinary medical products, including medical countermeasures, and monitors the nation's food and blood supplies for safety. In many cases, it is small businesses that are working on medical countermeasures development.
Without the involvement of small business, the nation’s medical countermeasures effort would be much further away from needed preparedness and response capabilities.
FDA’s medical countermeasures initiative has three key goals:
• Enhance FDA’s product review and approval processes for the highest priority MCMs and related technologies
• Build the necessary science base for MCM development and identify clear, efficient pathways for developing, manufacturing, and approving critical MCMs
• Modernize the statutory, regulatory, and policy framework to facilitate MCM development and ensure an effective public health response
Examples of some of the highest priorities of medical counter measures are:
• Monoclonal antibodies
• Drugs and cellular therapies, for example, to treat radiation injury
• Diagnostics that can identify multiple agents simultaneously
For additional information about medical countermeasures and to suggest topics for upcoming MCM webinars, e-mail AskMCMi@fda.hhs.gov